DepressionNCT03053765
Optimizing Fidelity of Interpersonal Psychotherapy
A study testing training in IPT in people with Depression, run by University of Iowa at 1 site in United States.
Trial summary
The study is designed to develop and validate an instrument to measure quality and adherence to IPT for research and training purposes. The measure is now being used to evaluate training in IPT. Read more about this study
- Who is it for?
- Ages 21 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Depression
- What is being tested?
- training in IPT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 115 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Aug 2012to 31 Jan 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Active and licensed therapist conducting psychotherapy treatment; naïve to training in IPT
Who cannot join
- Inactive or not treating patients
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Optimizing Fidelity of Interpersonal Psychotherapy for Depression
The study is designed to develop and validate an instrument to measure quality and adherence to IPT for research and training purposes. The measure is now being used to evaluate training in IPT.
Read the detailed description
The study is a randomized trial comparing 4 different methods of follow-up training in IPT. Following initial 2-day training, participant therapists will be randomized to either individual supervision, group supervision, an internet-based training program, or autodidactic training. Participants will be followed for a year to determine their use of IPT, outcomes with patients, and adherence and quality of IPT in 4 case portfolios. The adherence measure for IPT developed in Phase I of the project is being used as the gold standard measure of IPT fidelity.
- Conditions
- Depression
- Being tested
- training in IPT
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
training in IPTOther
Follow-up training in IPT to determine which best enhances fidelity
| Study group | Role | What they receive |
|---|---|---|
| Individual Supervision in IPT | Active comparator | Bi-weekly individual case supervision in IPT Receives: Other: training in IPT |
| Group Supervision in IPT | Experimental | Bi-weekly group supervision in IPT in groups of 4-6 therapists Receives: Other: training in IPT |
| Internet-Based Training in IPT | Experimental | Access to internet-based training in IPT to review information learned in initial 2-day training Receives: Other: training in IPT |
| Autodidactic Training in IPT | No intervention | Clinicians allowed access to training materials and can engage in self-study |
What is being measured
The primary outcome is the main question the study is designed to answer.
expert evaluation of conduct of IPT using IPT Quality and Adherence Measure
The "IPT Quality and Adherence Measure" is the title of a single outcome measure used to assess clinicians performance of IPT
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2017
- Study start3 Aug 2012
- Primary completion31 Jan 2020
- Study completion31 Jan 2020
Why it stopped: Conflict of Interest (COI) cannot be managed
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by University of IowaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 115 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Iowa
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Scott Stuart, MD, Principal investigator, University of Iowa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03053765
- Sponsor's protocol ID
- R33MH097041
- Status last verified
- Jun 2022
- First submitted
- 9 Aug 2016
- Last updated
- 9 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing Fidelity of Interpersonal Psychotherapy for Depression
- ClinicalTrials.gov ID
- NCT03053765
- Acronym / sponsor ID
- R33MH097041
- Conditions
- Depression
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Conflict of Interest (COI) cannot be managed
- Enrolment
- 115 participants (actual)
- Lead sponsor
- University of IowaUniversity, hospital or other
- Study start
- 3 Aug 2012 (actual)
- Primary completion
- 31 Jan 2020 (actual)
- Study completion
- 31 Jan 2020 (actual)
- First posted
- 15 Feb 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study is designed to develop and validate an instrument to measure quality and adherence to IPT for research and training purposes. The measure is now being used to evaluate training in IPT.
Detailed description
The study is a randomized trial comparing 4 different methods of follow-up training in IPT. Following initial 2-day training, participant therapists will be randomized to either individual supervision, group supervision, an internet-based training program, or autodidactic training. Participants will be followed for a year to determine their use of IPT, outcomes with patients, and adherence and quality of IPT in 4 case portfolios. The adherence measure for IPT developed in Phase I of the project is being used as the gold standard measure of IPT fidelity.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Individual Supervision in IPT | Active comparator | Other: training in IPTBi-weekly individual case supervision in IPT |
| Group Supervision in IPT | Experimental | Other: training in IPTBi-weekly group supervision in IPT in groups of 4-6 therapists |
| Internet-Based Training in IPT | Experimental | Other: training in IPTAccess to internet-based training in IPT to review information learned in initial 2-day training |
| Autodidactic Training in IPT | No intervention | –Clinicians allowed access to training materials and can engage in self-study |
Who may qualify
- Ages
- 21 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Active and licensed therapist conducting psychotherapy treatment; naïve to training in IPT
Key exclusion criteria (1 listed)
- Inactive or not treating patients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| training in IPTFollow-up training in IPT to determine which best enhances fidelity | Other | Group Supervision in IPT, Individual Supervision in IPT, Internet-Based Training in IPT |
Primary outcome
expert evaluation of conduct of IPT using IPT Quality and Adherence Measure
Time frame: one year
The "IPT Quality and Adherence Measure" is the title of a single outcome measure used to assess clinicians performance of IPT
Results and safety
The study was stopped early (reason given: Conflict of Interest (COI) cannot be managed). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Scott Stuart, MD principal investigator
University of Iowa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing training in IPT in people with Depression, run by University of Iowa at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 9 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Conflict of Interest (COI) cannot be managed). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
expert evaluation of conduct of IPT using IPT Quality and Adherence Measure (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2022.